Draft Research Plan
Sexually Transmitted Infections: Behavioral Counseling
January 16, 2025
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
This document is available for Public Comments until Feb 12, 2025 11:59 PM EST
In an effort to maintain a high level of transparency in our methods, we open our Draft Research Plan to a public comment period before we publish the final version.
Leave a Comment >>Abbreviations: STI=sexually transmitted infection; QoL=quality of life.
- Do behavioral counseling interventions that aim to decrease risky or increase protective sexual behaviors, or both, reduce sexually transmitted infections (STIs) or related morbidity and mortality?
- Do behavioral counseling interventions decrease risky or increase protective sexual behaviors that can reduce the risk of STIs?
- What potential harms are associated with behavioral counseling interventions to reduce STI infections?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What clinical risk assessment tools or guidance can be used to help primary care clinicians identify individuals at higher risk for STIs?
- What social, structural, and health system factors in the United States contribute to inequities in STI risk, and how can they be addressed to improve sexual health outcomes?
- Are there STI behavioral counseling interventions or modalities that have been developed to address the needs and concerns of specific populations with regard to gender, sexual practices or orientation, race or ethnicity, disability status, or other characteristics?
Health equity will be considered throughout the review using several approaches. For key questions, we will describe the population characteristics of the included studies to assess the degree to which the evidence is representative of diverse populations. We will also analyze benefits and harms of treatment interventions by specific populations to the extent that this is reported in the included studies for selected populations of interest. These groups include racial and ethnic groups, socioeconomic and insurance status, or other social risk factors. Depending on the study design and timing of studies, descriptions of study populations vary in their recognition of the presence of transgender, gender nonbinary, and gender expansive individuals. We will generally use the gender terminology used to describe included study populations; however, since anatomic, social, and behavioral factors contribute to STI risk, we will aim to characterize gender as specifically as possible when information is available, including sex assigned at birth when reported (e.g., cisgender, transgender).
The proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.
| Category | Included | Excluded |
|---|---|---|
| Aim | Studies targeting sexual behavior change to prevent STIs | Studies aimed solely at targeting behavior change to prevent unintended pregnancy or to change behaviors associated with risky sexual behavior (e.g., substance use disorders, interpersonal violence) |
| Condition | Any infection that is transmitted through sexual contact (i.e., oral, vaginal, or anal), including, but not limited to: HIV, human papillomavirus (HPV), herpes simplex virus (HSV) type 1 and 2, hepatitis B and C viruses, chlamydia, gonorrhea, syphilis, mpox, and trichomoniasis. | Infections acquired through nonsexual transmission routes (e.g., maternal-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with an infected person) |
| Population |
Adolescents and adults, including pregnant individuals |
Studies limited to populations requiring specialized healthcare or interventions to address STI health risks (e.g., HIV-positive individuals, commercial sex workers, persons who inject drugs) |
| Interventions |
Interventions involving behavioral counseling to prevent or reduce STIs (i.e., some provision of education, skills training, or guidance on how to change sexual behaviors) delivered alone or in combination with other interventions intended to promote sexual health and risk reduction or risk avoidance, which can feasibly be implemented in or referred from primary care. Interventions may include, but are not limited to:
|
Trials within closed pre-existing social networks (e.g., worksite or church programs) or within schools
|
| Comparators |
No intervention (e.g., waitlist) |
Active intervention (i.e., comparative effectiveness) |
| Outcomes | KQ 1 (Health outcomes):
KQ 2 (Behavioral outcomes):
KQ 3 (Harms):
|
|
| Setting |
Conducted in or recruited from primary care settings, including:
|
Research laboratories |
| Study design | Randomized, controlled trials and nonrandomized, controlled trials (controlled clinical trials) | Observational studies; comparative effectiveness trials without a control group |
| Timing of outcome assessment | ≥3 months post-baseline | <3 months post-baseline |
| Publication date | Published after 1999 (2000 to present) | Published in or before 1999 |
| Country | Studies conducted in countries categorized as “Very High” on the 2023/2024 Human Development Index (as defined by the United Nations Development Programme) | Countries with a Human Development Index other than “Very High” |
| Language | English only | Non-English publications |
| Study quality | Fair or good-quality studies | Poor-quality studies (according to design-specific USPSTF criteria) |
Abbreviations: AIDS = acquired immunodeficiency syndrome; doxy PEP = doxycycline post-exposure prophylaxis; HIV = human immunodeficiency virus; HSV = herpes simplex virus; KQ = key question; PrEP = pre-exposure prophylaxis; STI = sexually transmitted infections; USPSTF = U.S. Preventive Services Task Force.